| TGA Action ID |
RC-2023-RN-00920-1 |
| Type of Product |
Medicine |
| Product Name/Description |
DASATINIB DR. REDDY'S dasatinib 70 mg film coated tablet blister pack
Batch number: ZH20022
Expiry: Dec 2023
ARTG 337456 |
| ARTG Number |
337456 |
| Action Type |
Recall |
| Action Level |
Consumer |
| Hazard Classification |
Class II |
| Reason for the Action |
Dr Reddy's has observed out of specification results in dissolution test of Dasatinib 70 mg (Batch ZH20022) tablets during stability testing.
Failure in the dissolution test can result in incomplete release of the medicine and lack of efficacy.
This issue does not affect any other batches of Dasatinib Dr. Reddy’s Tablets or any other Dr.Reddy’s products. This batch has been distributed to hospitals and pharmacies since March 2022.
To date, there have been no reports of adverse events related to this issue. |
| Instructions for Customers/Users |
Retailers and distributors are to immediately quarantine the affected batch on site to prevent further use.
Pharmacists and healthcare providers are to contact patients who have been provided affected stock to arrange return. A copy of the customer letter is to be provided from healthcare providers to impacted patients.
This action has been finalised on 4/7/2024. |
| Action Commencement Date |
25/10/2023 |
| Responsible Entity |
|
| Contact Information |
03 8394 1888 - Dr Reddy's Laboratories |